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New FDA Drug Approvals - March 2024


fruquintinib

Fruzaqla

Pharmaceutical company: Takeda Pharmaceuticals

Pharmacologic classification: Kinase inhibitor

Therapeutic classification: Antineoplastic

AVAILABLE FORMS

Capsules: 1 mg, 5 mg
 

INDICATIONS AND DOSAGES

Metastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy

Adults: 5 mg PO once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity occurs.

Adjust-a-dose: For adverse reactions, first dosage reduction is to 4 mg PO once daily; second dosage reduction is to 3 mg PO once daily. Permanently discontinue the drug in patients unable to tolerate 3 mg PO once daily. Refer to the manufacturer's instructions for dosage adjustments related to adverse reactions.

CONTRAINDICATIONS AND CAUTIONS

  • This drug can cause hypertension, including hypertensive crisis. Don't initiate treatment unless blood pressure is adequately controlled.
  • This drug may increase the risk of serious or fatal hemorrhagic events, infections, or GI perforation or fistula.
  • This drug can cause liver injury. Use isn't recommended in patients with Child-Pugh class C liver impairment. Fruquintinib has not been sufficiently studied in patients with Child-Pugh class B liver impairment.
  • This drug can cause posterior reversible encephalopathy syndrome, resulting in subcortical vasogenic edema.
  • Impaired wound healing can occur in patients who receive VEGF inhibitors.
  • This drug may increase the risk of arterial thromboembolic events. Use cautiously when initiating therapy in patients with a recent history of thromboembolic events. The 1-mg capsules contain FD&C Yellow No. 5 (tartrazine) and Yellow No. 6 (sunset yellow FCF), which may cause allergic-type reactions (including bronchial asthma) in susceptible persons and is frequently seen in patients who also have aspirin hypersensitivity.
  • Safety and effectiveness in children haven't been established.
  • Dialyzable drug: Unknown.


PREGNANCY-LACTATION-REPRODUCTION

  • This drug can cause fetal harm. Patients and their partners of childbearing potential should use effective contraception during treatment and for 2 weeks after the last dose.
  • Verify pregnancy status of patients of reproductive potential prior to initiating this drug.
  • There are no data about this drug in human milk or its effects on a breastfed child or on milk production. Breastfeeding should be avoided during treatment and for 2 weeks after the last dose due to the potential for serious adverse reactions in the breastfed child.


INTERACTIONS

Drug-drug. Moderate CYP3A inducers (efavirenz): May decrease fruquintinib level. Avoid use together; if unavoidable, continue fruquintinib at recommended dosage.
Strong CYP3A inducers (rifampin): May decrease fruquintinib level. Don't use together.
Vaccines (inactivated): May diminish effect of vaccines. Give inactivated vaccines at least 2 weeks before stating fruquintinib when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 months after therapy is complete.
Vaccines (live): May diminish vaccine effect and increase risk of vaccine-associated infection. Avoid use together.

ADVERSE REACTIONS

CNS: asthenia, fatigue.
CV: hypertension, hemorrhage.
EENT: dysphonia, epistaxis, throat pain.
GI: stomatitis, abdominal pain, diarrhea, vomiting, GI hemorrhage, GI perforation, GI fistula, anorexia, intestinal obstruction.
GU: proteinuria, UTI, proctalgia, increased creatinine levels.
Hematologic: thrombocytopenia, anemia, lymphocytopenia, prolonged PTT.
Hepatic: increased LFTs.
Metabolic: hypothyroidism, hyperlipidemia, hyperglycemia, hypokalemia, hypocalcemia, hypoalbuminemia, hyponatremia, hypomagnesemia, hyperuricemia.
Musculoskeletal: musculoskeletal pain, arthralgia, back pain.
Respiratory: pneumonia, URI.
Skin: palmar-plantar erythrodysesthesia, rash.
Other: death.

Reactions in bold italics are life-threatening.
 

Released: March 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


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